Plant & Operation Validation : Life Science Solutions
ACCURACY, PRECISION, CONTROL: Did you get the results you were looking for? Can you repeat what you have done over and over again? Whether you are installing a new state of the art automated packaging line or calibrating a balance you have to have control. Within the biotech, medical device and pharmaceutical market sectors you have to be able to document proof of control industry regulations (i.e. FDA, ICH, JP, EP).
The bedrock of our client's future rests in the ability of their manufacturing facilities to operate consistently and reliably year after year. After spending millions and often billions of dollars our clients want to know they are going to get a return on their investment that's why Raland Technologies specializes in Plant Operational Design, Management and Validation. We assist our clients in ensuring their operations achieve efficient product throughput for the highest level of profitability all while meeting and exceeding industry regulations (GAMP/GMP).
Areas of Expertise
- Life Cycle and Opportunity Cost Analysis
- Develop Global Validation Strategy and Validation Master Plan
- Project Management
- Gap Analysis and Risk Mitigation
- Process Improvement
- On-site Staffing
Business Operation
- Author Standard Operating Procedures
- Capital Planning
- Controls & Automation (GAMP compliant)
- Facility Construction and Relocation
- Equipment Specification, Installation and Validation
- Design Specification (DS)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
- Supply Chain and Manufacturing Optimization
- Technology and Manufacturing Transfer
- Validation Operations
- Cleaning Validation
- Metrology
- Process Validation
- Temperature Distribution and/or Penetration Studies
- Test Script Authoring and Reviews